Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03425500 |
| Other study ID # |
IW-002 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2018 |
| Est. completion date |
August 2025 |
Study information
| Verified date |
August 2023 |
| Source |
Nova Scotia Health Authority |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
To compare bridging reconstruction to superior capsular reconstruction using human dermal
allograft augmentation for repair of massive rotator cuff tears.
Description:
A total of 60 patients will be enrolled in the study. In the pre-operative period, there will
be no additional time requirements for the patient, except for the informed consent process
for the study. Routine radiographs including an AP and Y view of the shoulder as well as a
pre-operative MRI are obtained for all patients undergoing rotator cuff surgery.
The patients will complete a structured clinical examination conducted by a sports medicine
fellowship trained orthopaedic consultant. The examination will consist of range of motion
testing by goniometer as well as strength testing by hand dynamometer. The patient will also
complete the WORC questionnaire.
Surgical Technique
All patients will undergo a 15-point arthroscopic shoulder examination as per the method
outlined by Snyder. An arthroscopic acromioplasty will be performed if needed according to
the technique described by Snyder. The bursal side of the tear will be evaluated. If the cuff
can be re-approximated to its anatomic position on the greater tuberosity without excessive
tension, a standard rotator cuff reconstruction will be attempted. If this is not possible
the surgeon will determine that the cuff is "irreparable" and the randomization envelope will
be opened.
Wong et al. described the surgical procedure for patients in the "Bridging" group. The bursa
will be debrided thoroughly and rotator cuff edges will be shaved down to stable tissue.
Following this, an acellular human dermal patch will be rehydrated in saline solution for 15
minutes. The patch is stretched to remove the manufacturing surface irregularities. The patch
is then sewn in place with braided polyester suture material. Multiple sutures, approximately
5 to 10 mm apart from one another will be used. The medial sutures are placed into the
remnants of supraspinatus and infraspinatus tendons. The patch is then attached to the
greater tuberosity in a double row configuration.
The technique described by Burkhart et al will be followed for patients in the "SCR" group.
The bursa will be debrided thoroughly and rotator cuff edges will be shaved down to stable
tissue. Following this, an acellular human dermal patch will be rehydrated in saline solution
for 15 minutes. The patch is stretched to remove the manufacturing surface irregularities.
Measurement of defect size (coronal and sagittal) will take place, following that the glenoid
and humeral footprint preparation will be performed utilizing an arthroscopic burr,
arthroscopic bone anchors will be inserted on the glenoid footprint and graft is inserted
with double pully technique. The graft is then tensioned to greater tuberosity using a double
row configuration.
Postoperative protocol
The shoulder will be immobilized in a sling for one week postoperatively, and only passive
forward flexion and external rotation will be allowed for eight weeks. The patient then
progresses to active shoulder motion. Strengthening will begin at twelve weeks
postoperatively.
The patient will follow-up with the attending surgeon (IW) at 2 weeks post-operatively for a
wound check. Then further follow-up appointments will be at 6 weeks, 3 months, 6 months, 12
and 24 months, as per current clinical practice.
At the 3, 6, 12, and 24 month visits the patient will again undergo the structured clinical
examination conducted by a sports medicine fellowship trained orthopaedic consultant who is
blinded to the patients' treatment group. The patient will also complete the (WORC)
questionnaire at these follow-up appointments. Radiograph will be taken also to obtain the
postoperative measurements. MRI will be done to assess healing at 12 months.
